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The purpose of this study is to examines the effectiveness of Core stabilization exercise on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain.
This study is to compare the effectiveness of Core stabilization exercise and physical therapy on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain. There are 2 groups receiving 2 different kinds of intervention: treatment group receiving core stabilization exercise (CSE) and control group receiving physical therapy including therapeutic ultrasound and hydrocollator pack. Each intervention will perform for 7 weeks. The patients will assess for all outcome measures at baseline, 7 weeks of intervention, and 1- month follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core stabilization exercise | Active Comparator | 7-weeks of core stabilization exercise |
|
| conventional treatment | Active Comparator | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core stabilization exercise | Other | 7-weeks of core stabilization exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7 | The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score) | baseline an week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7 | This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rungthip Chalermsan | Faculty of Associated Medical Sciences, Khon Kaen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Associated Medical Sciences, Khon Kaen University | Khon Kaen | Changwat Khon Kaen | 40002 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Stabilization Exercise | 7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in |
| FG001 | Conventional Treatment | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The data was presented as means, standard deviations (SD) and 95% CI. The statistical analysis performed using SPSS version 16.0 for windows (IBM Corporation, Armonk, NY, USA). The Shapiro-Wilk used to test for the normality of the data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Core Stabilization Exercise | 7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7 | The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score) | Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group. | Posted | Mean | Standard Deviation | units on a scale | baseline an week 7 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Core Stabilization Exercise | 7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rungthip Chalermsan | Khonkaen University | +66 835603675 | chalermsanrungthip@gmail.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Conventional treatment |
| Other |
7-weeks of conventional treatment include therapeutic ultrasound and hot pack |
|
| baseline and week 7 |
| Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7 | Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score) | baseline and week 7 |
| Change From Baseline in Repositioning Error on Repositioning Test at Week 7 | This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score) | baseline and week 7 |
| BG001 | Conventional Treatment | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Conventional Treatment | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound. |
|
|
|
| Secondary | Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7 | This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score | Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group | Posted | Mean | Standard Deviation | units on a scale | baseline and week 7 |
|
|
|
|
| Secondary | Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7 | Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score) | Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group | Posted | Mean | Standard Deviation | centimeter | baseline and week 7 |
|
|
|
|
| Secondary | Change From Baseline in Repositioning Error on Repositioning Test at Week 7 | This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score) | Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group | Posted | Mean | Standard Deviation | centimeter | baseline and week 7 |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Conventional Treatment | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound. | 0 | 19 | 0 | 19 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |